The testing is the final element required before it can lodge a 510(k) submission to the United States Food and Drug Administration (FDA).
Subject to FDA granting approval, the first-generation Rover will then be available for sale in the United States including to the US Army Medical Materiel Agency who have expressed strong interest in trialling the Rover.
Regulatory filings in other jurisdictions including Europe and Australia are also planned to enable sales to the UK Ministry of Defence and the Australian Defence Force.
The Rover will become Micro-X’s second product but the first sold under its own name.
Its first lightweight mobile x-ray product, the DRX Revolution Nano, carries the name of its US distributor, Carestream Helath, and has experienced a surge of orders during the coronavirus pandemic.
Micro-X’s Managing Director, Peter Rowland said the series of IEC 60601-1 tests mark the conclusion of the Rover design phase.
“The Rover will also be the first mobile X-ray unit which has been purpose-designed for deployed military operations and which incorporates many features specifically requested by military users to optimise its performance in this demanding deployed environment,” he said.
“We are focussing our sales efforts in being able to secure a first sale of the Rover this year and to facilitate that we plan to lodge a 510(k) submission with the FDA in the coming weeks.”
Micro-X has also embarked on a $15 million Placement and Entitlement Offer, so far raising about $10.6 million in April and May.
The funding will be used to finalise the high-power generator for the Rover, which has moved into the execution phase.
The 9-12 month project is another key step in the commercialisation of the Rover Mark II, the high-power version of the Rover intended for volume sales following regulatory approval.
Micro-X is also developing a mobile backscatter imager for the remote detection of improvised explosive devices and a mobile baggage scanner for airports.
The company relocated from Victoria to South Australia in 2015 to establish a manufacturing hub at the Tonsley Innovation Precinct, a former Mitsubishi car assembly site in Adelaide’s southern suburbs.
It also listed on the Australian Securities Exchange in December 2015 and launched the DRX Revolution Nano in 2017.
The units are manufactured using carbon nanotubes, making the Nano several times lighter and more compact than traditional x-ray machines.
The company with a market capitalisation of $50 million announced last week it had shipped and invoiced Nano units worth $2.2 million since January and reduced delivery times for new orders to four weeks or less.
Jump to next article